The foundation of PHUSE's events lies in the submitted presentation content. PHUSE have long acknowledged those who contribute exceptional content to drive our event agendas forward, and this commitment to recognising the best contributors remains steadfast.
| Stream | Presentation Title | Author(s) | View Presentation |
|---|---|---|---|
Analytics & Statistics | Consistency, Speed and Satisfaction: The Impact of TLF Mock Shell Centralisation | Jie Yang | View Now |
Artificial Intelligence, Machine Learning, AI and Large Language Models | Utilising AI for Automated Conversion of ADaM Specifications to R Code | Kjersten Offenbecker & Alice Ehmann | View Now |
Data Handling & Engineering | Semi-automating Case Report Form Annotations Using Python and a Metadata Repository | Alvin Mathew | View Now |
Data Standards & Governance and Implementation | Multiple Sclerosis Trials Unpacked: Standards, Endpoints and Programming Experience | Daryna Teteriuk | View Now |
Data Visualisations | Straight to the Source: Interactive Visual Dashboards for Data Cleaning | Daniel Smith | View Now |
Emerging Trends & Innovation | Automated Code Generation: Evaluating Deterministic and Probabilistic Approaches | Malan Bosman | View Now |
Open Source Technologies | Harmonising gsm and the pharmaverse: Orchestrating SDTM, ADaM, TFLs and ARS in a Unified R Workflow | Zelos Zhu | View Now |
Poster Presentations | End-to-End Workflow for CDISC Estimand Framework in Clinical Trials | Hiral Raval & Simon Luo | View Now |
Professional Development | Developing the Workforce of the Future | Avinash Pati | View Now |
Real-world Evidence | Robust Causal Inference in Real-World Evidence Studies with Double Machine Learning | Jing Dai & Yilun Huang | View Now |
Risk-based Quality Monitoring | {gsm} Operations – Implementing an Open Central Monitoring Framework Jenn Krohn & | Jeremy Wildfire | View Now |
Scripts, Macros & Automation | AUTOCODE: Metadata-Driven Automation for Faster, Traceable SDTM and ADaM Programming | Matthew Finnemeyer | View Now |
Submissions & Agencies | Breaking Free from the xpt: Exploration of DatasetJSON as an Alternative Transport File to Regulatory Agencies | Ben Straub & Sam Parmar | View Now |
| Stream | Presentation Title | Author(s) | View Presentation |
|---|---|---|---|
Application Development | Harnessing the Power of the Safety Database | Ravichandra Hugar & Aparna Sarju | View Now |
Analytics & Statistics & Analytical Risk-Based Monitoring | From Information to Insights: Harnessing Centralised Monitoring in RBQM to Proactively Identify and Mitigate Risks in Clinical Trials | Bismita Borkakoty & Priyangshu Chowdhury | View Now |
Coding Tips & Tricks | aRe you ready! Fun, Fast and Functional Coding Tips | Xeviers Koner | View Now |
Data Standards, Governance, Implementation, Submissions & Agencies | Optimising ADaM Workflow with the {AiR} Internal R Package – BDS | Dhivya Kanagaraj & Arjun Rubalingam | View Now |
Emerging Trends & Open Source Technologies | Integrating R Programming and Generative AI for Prompt-Driven Clinical Trial Data Analysis | Vyom Bhatt | View Now |
Machine Learning, AI, Large Language Models, Data Handling & Data Engineering | Don't Panic! Embracing AI as Your Superpower in Statistical Programming | Amruta Nambiar | View Now |
Poster Presentations | R You Ready for SDTM? Let {sdtm.oak} Do the Heavy Lifting | Sangram Parbhane & Sandeep Mulay | View Now |
Professional Development | From Trails to Triumphs: Harnessing Nature's Lessons for Professional Development | Tanushree Srivastava | View Now |
Real-world Evidence & Data Visualisation | External Comparator Arms: Redefining Control in the Era of Real-World Data | Vishal Goriya & Anshul Sinha | View Now |
Scripts, Macros & Automation | From Document to Derivation: Automating ADaM Variable and Endpoint Code Generation Using Study Specifications and Clinical Documents | Sruthy Biju & Alisha D | View Now |
| Stream | Presentation Title | Author(s) | View Presentation |
|---|---|---|---|
Application Development | The Key Features Every Statistical Computing Environment Should Have and Often Lacks. A Presentation About Almost 20 Years of Experiences with SCEs | Michael Weiss & Elena Glathe | View Now |
Analytics & Statistics | Blinded & Coordinated: Aligning People and Processes To Prevent Unblinding | Monika Bajek & Dubravka Georgijevic | View Now |
Coding Tips & Tricks | Building Reusable Precision Logic in SAS Using PROC FCMP | Mariam Babayan & Syuzanna Simonyan | View Now |
Data Handling & Data Engineering | A Splash in Time – Insights into a Data Pooling Time Machine | Lutz Hoffmann & Dana Vinzelberg | View Now |
Data Standards & Governance | ADaM Conformance Rules: Bridging the Gap Between Standards and Practice | Rafik Ghazaryan | View Now |
Leadership Through Innovation | Landing Moonshots | Ross Farrugia | View Now |
Machine Learning, AI & Large Language Models | Talk to Your Data: Accelerating Insights with AI-Powered RShiny | Emily Yates | View Now |
Open Source Technologies | Advancing Automated NonCompartmental Analysis with R Shiny | Jana Spinner & Gerardo Rodriguez | View Now |
Professional Development | Debug Your ‘Work Language’ | Jessica Anderson | View Now |
People Leadership & Management | The Human Element: Synergising Emotional and Physical Intelligence in Statistical Programming Leadership | Harris Kampouris | View Now |
Poster Presentations | Shots to Stats: AI's Take on Alcohol Units | Liam Clothier | View Now |
Real-world Evidence | Unlocking Healthcare Insights: Graph-Based Modelling and Analysis of Synthetic Patient Data | George Panagoitakis & Nikolaos Kountouris | View Now |
Submissions & Agencies | Diversity, Inclusion and Equality – It’s Just Good Science! | Roxanne McGuire | View Now |
Standards Implementation | The Chicken, the Egg and the ADaM: Cracking the PRE-ADSL vs ADSL Sequence | Carla Santillan | View Now |
Scripts, Macros & Automation | More Science, Less Bookkeeping: Our Path to Hyper-Efficient ADaM Program Generation via AI, Process Improvements, and Good Old-Fashioned Programming | Matthew Phelps & Nicolai Skov Johnsen | View Now |
Trends & Technology | Digital SAP Model Using Biomedical Concepts | Tom Ratford | View Now |
| Category | Poster Title | Author(s) | View Poster |
|---|---|---|---|
Industry | PP05: GitLab vs GitHub: The Battle of the Repositories | Amaya Opalka, Roche | View Now |
Collaboration | PP19: Representing Virtual Control Animal Data in SEND | Gitte Frausing, Data Standards Decisions, Frank Bringezu, Merck, Christy Kubin, Charles River Laboratories & William Houser, Bristol Myers Squibb | View Now |
| Stream | Presentation Title | Author(s) | View Presentation |
|---|---|---|---|
Analytics & Statistics | Multiple Imputation in Composite Endpoints - It’s Not That Hard! | Ashley Mao | View Now |
Analytical Risk-based Monitoring | Risk Based Quality Management (RBQM) in Clinical Data Management | Anna Górecka & Marcin Kot | View Now |
Data Handling & Engineering | Demystify the Handling and Mapping of External Data to CDISC Standards in Clinical Trials | Vamsi Kandimalla & Murali Kanakenahalli | View Now |
Data Standards, Governance & Implementation | End-to-End Therapeutic Area Data Standards Development and Governance – A Case Study Involving CRS and ICANS | Yaling Teng | View Now |
Emerging Trends | Automating SAS and R Code Interpretation and Debugging: A Practical Pipeline for Statistical Programmers | Jaime Yan & Tingting Tian | View Now |
Machine Learning, AI & Large Language Models | Scaling Up: Accelerating Self-Hosted Open-Access LLMs to Compete with the Big Three (ChatGPT, Claude, Gemini) | Kostiantyn Drach & Iryna Kotenko | View Now |
Open Source Technologies | Unleashing the Power of {teal}: New Features and Cross-Industry Collaboration | Nina Qi & Dony Unardi | View Now |
Poster Presentations | From Topline to Triumph: Visualising the Pathways to Regulatory Approval | Jasperlynn Kao | View Now |
Professional Development | Harmonising Heterogeneity: Orchestrating Innovation Through Interdisciplinary Collaboration and Strategic Alignment | Dorothy Dlamini & Srinivas Veeragoni | View Now |
Real-world Evidence | Real-World Data – Analysis-Ready Datasets: A Standardised, Specialised and Innovative Data Solution for Efficient Real-World Data Analysis | Nayan Chaudhary & Navdeep Pal | View Now |
Scripts, Macros & Automation | Using Large Language Models for Consistency Checking of Tables, Listings and Graphs | Yingying Wei | View Now |
Submissions & Agencies | From Application to Approval: Exploring the FDA’s Review Process | Kiran Bonda | View Now |
| Stream | Presentation Title | Author(s) | View Presentation |
|---|---|---|---|
Application Development | AD04: Advancing Kidney Assessments for Transplants with AI-driven Applications | Federica Citterio & Soundarya Palanisamy, SAS | View Now |
Analytical Risk-based Monitoring | AR03: Quality Tolerance Limits: Understanding the Added Value and Statistical Need of Implementing QTLs to Assure Subject Safety and Data Quality | Nathalie van Borrendam & Agnes Verhoeven, Johnson & Johnson | View Now |
Analytics & Statistics | AS04: Comparison of the Wilcoxon-Signed Rank Test with the Hodges-Lehmann Estimator in SAS, R and StatXact as Part of the PHUSE CAMIS Project | Agnieszka Tomczyk & Lyn Taylor, PAREXEL | View Now |
Coding Tips & Tricks | Getting a Prompt Response Using ChatGPT and SAS | Stephen McCawille, Daiichi Sankyo | View Now |
Data Handling & Data Engineering | DH14: Transcriptomics – A Demanding Data Analysis that Expands the Limits of Regulated Clinical Data Handling | Lea Hildebrandt, Novo Nordisk | View Now |
Data Standards & Governance | DS13: Estimands: How to Make ADaM Implementation Your Friend | Jaclyn Amberg & Dennis Kusian, Metronomia Clinical Research | View Now |
Data Visualisation | DV05: Interactive Reporting Using FDA Standard Safety Shells and the CDISC Analysis Results Standard | Megan Harries & Steve Mallett, Veramed | View Now |
Leadership Through Innovation | LI05: Trustworthy and Responsible AI in Healthcare and Life Sciences From a Leadership Perspective | Mark Lambrecht, SAS | View Now |
Machine Learning, AI and Large Language Models | ML18: Hi. I Am a Chatbot. How Can I Help You? Enhancing the Reliability and Traceability of Large Language Models | Vicky Poulsen & Anya Vrecer, Novo Nordisk | View Now |
Open Source Technologies | OS07: Two Hats, One Noggin: Working as a Developer and as a User of the Admiral R Package for Creating ADaM | Edoardo Mancini, Roche & Ben Straub, GSK | View Now |
Professional Development | PD09: Four Languages, Three Years: An Agile Approach to Data Science | Shannon Haughton, GSK | View Now |
People Leadership & Management | PM03: Dealing with the Poor Performer | Stephen Prust, elderbrook solutions | View Now |
Poster Presentations | PP07: Building CORE Strength: An Implementation Exercise | Stine Bertelsen & Addie Olsen, Novo Nordisk | View Now |
Real-world Evidence | RE03: Future Clinical Data Submission Standards: CDISC, FHIR, OMOP, or Hybrid Model | Jeffrey Abolafia, Pinnacle 21 by Certara, Sarah Ferko & Ingeborg Holt, IBM | View Now |
Submissions & Agencies | SA06: Harmonising FDA and PMDA Submission Requirements | Luca Semeraro, Alira Health | View Now |
Standards Implementation | SI04: Mapping a Veeva SDS Specification to ODM-XML | Jørgen Iversen, Novo Nordisk | View Now |
Scripts, Macros & Automation | SM03: Optimising Workflow and Collaboration in a Pooled Coding Environment for Clinical Development | Louise Nørgaard, Novo Nordisk | View Now |
Trends & Technology | TT02: Working with Omics Data – A Statistical Programmer’s Perspective | Adrian Czaban, Novo Nordisk | View Now |
| Category | Poster Title | Author(s) | View Poster |
|---|---|---|---|
Industry | PP18: Bridging the Gap – Enhancing Analysis Results Generation with the CDISC ARS Model and the Community TFL Designer | Bhavin Busa, Clymb Clinical | View Now |
Collaboration | PP03: SEND (Standard for Exchange of Nonclinical Data) Industry Feedback Survey: 2024 Results | Vanessa Chavez, Labcorp & Lindsy Eickhoff, Inotiv | View Now |
FDA | PP23: A Framework Enabling LLMS into Regulatory Environment for Transparency and trustworthiness and its Application to Drug Labelling Document | Shraddha Thakkar, FDA | View Now |
| Stream | Presentation Title | Author(s) | View Presentation |
|---|---|---|---|
Analytical Risk-based Monitoring | AR01: My Data Is Too Good to Be True! Should I Worry About Fraud or Sloppiness? | Michael Walega, Bristol Myers Squibb & Johann Proeve, Cyntegrity | View Now |
Analytics & Statistics | AS05: Spline Analysis to Understand the Non-linear Relationship in Clinical Research | Anwaya Joshi, Cytel | View Now |
Data Handling & Engineering | DH02: Eliminating SDTM Double Programming by Using a Validation Tool and Dummy Data | Glenn Borgmans & Tine Seeuws, SGS Health Science | View Now |
Data Standards & Governance | DS05: Approaching End-to-End Analysis Standardisation in Global and Therapeutic Areas Level | Rudra Sheth & Xiaohan Zou, Bristol Myers Squibb | View Now |
Data Visualisation | DV05: Statistical Monitoring Report: A Path Forward to Interactive Data Analysis and Quantitative Decision-Making | Debopriya Ghosh & Xiang Li, Johnson & Johnson | View Now |
Emerging Trends | ET08: AI Exploration and Innovation for the Clinical Data Scientist | Cole Arendt & Phil Bowsher, Posit | View Now |
Open Source Technologies | OS03: NEST: How Could We Generate and Deliver Clinical Insights Even Faster? | Vincent Shen, Roche | View Now |
People Leadership & Management | PM03: Leadership Insights – Let’s Learn How to Lead the Leaders | Rachna Mittal, Genentech | View Now |
Poster Presentations | PP07: Sowing Seeds of Inspiration: Letters to a Pre-Scientist | Julie Ann Hood, Pinnacle 21 by Certara | View Now |
Professional Development | PD03: Recruiting the Best Talent and Developing them within the Organisation | Madhusudhan Reddy Papasani & Naveen Kommurur, Merck | View Now |
Real-world Evidence | RE03: Future Clinical Data Submission Standards: CDISC, FHIR, OMOP, or Hybrid Model | Jeffrey Abolafia, Pinnacle 21 by Certara | View Now |
Scripts, Macros & Automation | SM10: A Practical Approach to Automating SDTM Using a Metadata-Driven Method that Leverages eCRF Specifications and SDTM Programming Standards | Xiangchen (Bob) Cui & Min Chen, CRISPR Therapeutics | View Now |
Standards Implementation | SI02: Automating ADaM Creation in Clinical Trials Part 2 | Rie Ichihashi & Lyubov Sushchenko, Sanofi | View Now |
Submissions & Agencies | SA03: Demystifying Submissions to NMPA China | Dyuthi Yellamraju & Hiral Raval, Genentech | View Now |
Therapeutic Areas Specific Topics | TA04: Are Platform Trials the Need of the Hour for Oncology Trials? | Vidya Muthukumar, IQVIA | View Now |
| Stream | Presentation Title | Author(s) | View Presentation |
|---|---|---|---|
Application Development | AD15: Janssen DATA4YOU Platform Approach for Clinical Data Review | Erik Lemmens & Paul Foole, Johnson & Johnson | View Now |
Analytical Risk-based Monitoring | AR07: Risk-Based Monitoring in Clinical Trials with Machine-Learning-Powered Anomaly Detection | Ece Kavalci & Zaid Al-Jubouri, Lindus Health | View Now |
Analytics & Statistics | AS10: Comparison of Power Between Different Recurrent Events Analysis Methods Using Simulation | Soumitra Kar, Novo Nordisk | View Now |
Coding Tips & Tricks | CT05: Dynamic Testing for Empty Datasets | Timothy Lachlan-Cope, AstraZeneca | View Now |
Connected Health & Machine Learning | CM06: Unleashing the Power of Large Language Models for Clinical Data Approaches: Will AI Chatbots such as ChatGPT/Bard Replace Statistical Programmers and Statisticians Over Time? | Ercan Suekuer, Roche | View Now |
Data Handling & Data Engineering | DH02: How Can Python Be Used in Clinical Trials? | Pierre Dostie & András Kása, UCB Biosciences | View Now |
Data Standards & Governance | DS07: Automated Pipelines for Non-CRF Value-Level Metadata: A Meta-Programming Approach | Selena Baset & Philipp Thomas Ernst, Roche | View Now |
Data Visualisation | DV01: Will R/Shiny Provide a Novel Way for Study Teams to Review Clinical Data? | Gustav Söderström, AstraZeneca | View Now |
Leadership Through Innovation | LI03: Road to Rome or Roaming – A Reprise | Christian Müller, Roche & Francis Kendall, AstraZeneca | View Now |
Professional Development | PD05: Mastering the Art of Adaptation: Innovative Strategies for Effective Change Management | Mark Bynens, Johnson & Johnson | View Now |
People Leadership & Management | PM06: Statistical Programming – Hiring Mission Made Possible | Christoph Ziegler & Donald Paterson, Johnson & Johnson | View Now |
Poster Presentations | PP16: CDISC’s ADTTE Domain: Time-to-Event Analysis From a Programmer’s Point of View | Vitali Gering & Sophia Praeger, Chrestos Concept | View Now |
Real-world Evidence | RE06: The Curious Case of Observational Studies – A Programmer’s Dilemma | Vikas Shokeen, Novartis | View Now |
Submissions & Agencies | SA07: Development Safety Update Report (DSUR)/Periodic Safety Update Report (PSUR) | Phillip Spowart, Fortrea | View Now |
Software Demonstrations | SD04: Digitalisation of Specifications – Enabling the Next Generation of Clinical Trials | Rebecca Bates & Nekzad Shroff, Saama Technologies | View Now |
Standards Implementation | SI02: Oak Garden – Metadata-Driven SDTM Automation in R | Magdalena Krochmal & Amy Franklin, Roche | View Now |
Scripts, Macros & Automation | SM02: Same But Different: Leveraging R for Comparing Clinical Study TFL Versions | Tiina Kirsilä, Novartis & Anna Wiksten, Bristol Myers Squibb | View Now |
